Cyclosporine (Sandoz Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed the drug Cyclosporine. It is used after organ transplantations to help prevent organ rejection, or to treat autoimmune conditions such as severe psoriasis, severe rheumatoid arthritis and nephrotic syndrome.

Cyclosporine is the brand name for a drug called "cyclosporine". It belongs to a family of drugs known as "immunosuppressants". These drugs work to "suppress" or reduce the body's immune response.

What it does:

Your body's immune system normally works to protect you from infections and other foreign material. When you receive a transplant, this system does not recognize the new organ, and will try to reject it.

Cyclosporine works to reduce this response, so your body is more likely to accept the new organ.

Cyclosporine do not completely suppresses the immune system, so your body will still have some infection-fighting ability.

Cyclosporine may be given alone, but is often given with other drugs which also suppress your immune system. Together these help prolong the life of an organ transplant, or to suppress certain function of your immune system to treat your psoriasis, rheumatoid arthritis or nephrotic syndrome.

When it should not be used:

Do not use Cyclosporine if you have ever had a bad, unusual or allergic reaction to cyclosporine or any of the non-medicinal ingredients of Cyclosporine.

For the treatment of psoriasis and rheumatoid arthritis, do not take Cyclosporine if you have one of the following conditions:

• abnormal kidney function;
• uncontrolled blood pressure;
• any type of cancer (except a skin cancer which is not a melanoma);
• uncontrolled infection (not treated or cured);
• inherited or acquired immune deficiency.

What the medicinal ingredient is:

Cyclosporine contains cyclosporine for microemulsion.

CYCLOSPORINE is the microemulsion formulation of cyclosporine which can be taken orally.

The "microemulsion" formulation allows more reliable absorption of cyclosporine from your stomach compared to conventional types of oral dosage forms. This means almost the same amount will go into your body each time you take the drug, and that food will have less of an effect on the amount of cyclosporine that gets absorbed.

What the important non-medicinal ingredients are:

Non-medicinal ingredients for Cyclosporine capsules are the following: Dehydrated Alcohol, D-" tocopheryl, Polyethylene glycol, Macrogol-glycerol hydroxystearate. Capsule shell: gelatin, sorbitol, glycerin.

What dosage forms it comes in:

Cyclosporine comes in one form: a soft gelatin capsule

Capsules

Cyclosporine capsules come with 25, 50 or 100 mg of cyclosporine. Each capsule is contained in a foil strip of 10 capsules, 30 capsules per box.

WARNINGS AND PRECAUTIONS

Medicines which suppress the immune system, such as Cyclosporine may influence your body’s ability to fight against infection and may increase the risk of developing cancers, particularly of the skin and lymphoid system. Therefore you should limit your exposure to sunlight and UV light by wearing appropriate protective clothing and frequently applying a sunscreen with a high protection factor.

Tell all health professionals you see (doctor, dentists, nurses, pharmacists) that you are taking Cyclosporine. It is also a good idea to wear a medic-alert bracelet.

Before you use Cyclosporine talk to your doctor or pharmacist if:

• You have any current or have had past health conditions.
• You are taking other drugs: Do not take any other drugs without asking your doctor or pharmacist first including over-the-counter medicines and herbal or home remedies. Cyclosporine is often given with other medicines. Make sure you know if you are to stop, or to continue, other immunosuppressant drugs you had been taking.
• You are to receive vaccinations: Cyclosporine may make vaccinations less effective or increase your risk of getting an illness from a live vaccine. Always discuss this possibility with your doctor before you get any vaccinations or immunizations.
• You receive Cyclosporine for psoriasis, rheumatoid arthritis, or nephrotic syndrome, your renal function and blood pressure should be checked before initiation of therapy and regularly thereafter. If high blood pressure develops during therapy and cannot be controlled, treatment should be stopped.

• You are or become pregnant: There is an increased risk of difficult pregnancies (up to 25% of pregnancies) in patients who have taken cyclosporine during pregnancy. These difficult pregnancies have resulted in an increased risk to the babies during and immediately after birth. As well, some babies have been born with abnormalities.

For these reasons it is recommended that you do not take Cyclosporine if you are, or become, pregnant. During your treatment with Cyclosporine and for 2 months after stopping your Cyclosporine treatment, you must use a reliable method of birth control. Should you become pregnant during the time you are taking your Cyclosporine you should inform your doctor at once. You will want to discuss the possible benefits and risks of continuing with this drug.

• You are breast-feeding: Do not breast feed your baby if you are taking Cyclosporine as it passes into breast milk and may harm your baby.

Do not stop taking Cyclosporine on your own even if you have been taking it for several years. Transplant patients: Although you may not notice any symptoms of rejection for several weeks, missing even a few doses of Cyclosporine may lead to rejection of your transplanted organ.

INTERACTIONS WITH THIS MEDICATION

Make sure your doctor knows if you are taking, or begin to take, any other medicines, including drugs, or herbal (natural) products that you can buy without a prescription while you take Cyclosporine. Some medicines may interact with Cyclosporine such as:

• weak analgesic drugs (non-steroid anti-inflammatory drugs),
• digoxin,
• caspofungin
• colchicines,
• HMG-CoA reductase inhibitors (statins),
• prednisolone,
• fibric acid derivatives (e.g . bezafibrate, fenofibrate) .
• methotrexate
• lercanidipine
• potassium sparing drugs (e.g . potassium sparing diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists)
• potassium containing drugs
• bosentan
• oxcarbazepine
• voriconazole

Never take Cyclosporine with grapefruit juice.

Cyclosporine is also used in combination with other immunosuppressive agents. However, do not use it together with other calcineurin inhibitors such as tacrolimus.

PROPER USEOF THIS MEDICATION

Usual dose:

• Always take Cyclosporine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. Do not change the dose on your own, no matter how you are feeling. Blood tests are one of the ways your doctor tells how much Cyclosporine you need. Based on these tests, and on your response to this drug, your doctor may change your dose from time to time.
• Space your doses of Cyclosporine as evenly as you can throughout the day. For example, if you take the drug 2 times a day, leave about 12 hours between each dose.

• Try to take your dose(s) at the same time(s) each day. This will help keep a constant amount of drug in your body and will also help you remember each dose. Cyclosporine may be taken with or without food. But it is best to be consistent: once you decide when you are going to take it in relation to food, do it the same way each time.

• Never take Cyclosporine with grapefruit juice.
• Leave the capsules in the foil until you need a dose. When you are ready to take a dose, remove the number of capsules you need to make up the dose your doctor prescribed.
• Swallow the capsules whole. You may use any kind of drink except grapefruit juice.

Missed Dose:

• For transplant patients, missing even a few doses of Cyclosporine may lead to rejection of your transplanted organ. That is why it is so important to take each of the doses your doctor prescribes.
• Talk to your doctor, nurse or pharmacist if you have trouble remembering doses, or if you are uncertain about how to take them. Also be sure to discuss any concerns you have about taking this drug as prescribed. These people can often suggest ways to overcome problems you have taking your medication.
• Never allow your medication to run out between refills. Plan to order your refills about one week ahead of time — that way you will always have a supply in case the pharmacy is closed or out of the drug. Also be sure to take enough medication with you when you go on a holiday.
• If you ever do miss a dose of Cyclosporine, do not try to catch up on your own. Instead, call your doctor or pharmacist right away for advice. It is also a good idea to ask your doctor ahead of time what to do about missed doses.

Be sure to keep all appointments at your clinic. Some of these visits will be used to check the level of cyclosporine in your blood. For transplant patients, levels that are too low can cause transplant rejection, while levels that are too high may cause damage to other organs. It is therefore very important not to miss any tests or check-ups your doctor orders.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Cyclosporine causes side effects in some people. Be sure to talk to your doctor if you have any concerns about this.

The most common side effects noted were:

• high blood pressure;
• kidney or liver problems;
• headache;
• increased levels of lipids (e.g . cholesterol) in the blood;
• loss of appetite, nausea, vomiting or diarrhea;
• acne or oily skin;
• slight trembling of the hands;
• increased growth of fine hairs on the body;
• muscle or joint pains or cramping;
• weakness, anxiety;
• tingling in the fingers, toes or mouth;
• night sweats; hearing loss; swelling of the face;
• increased potassium in the body (your doctor may instruct you to avoid high dietary potassium intake);

• tender or swollen gums

  • Because Cyclosporine reduces the function of your immune system, you are more likely to get bacterial, fungal or viral infections. To help reduce complications from these infections, tell your doctor right away about any cold or flu-like symptoms (such as a fever or sore throat), any boils on your skin, or pain when you urinate (pass your water).
  • The decreased function of your immune system may also increase your chances of developing cancer. Although very rare, cancers of the white blood cells (lymphomas) and other types of cancer have occurred in people taking cyclosporine. The following are some possible warning signs of cancer. To help detect any cancers as soon as possible, report any of these symptoms to your doctor right away: a change in your bowel or bladder habits; any sore that doesn't heal; unusual bleeding or discharge; the appearance of a lump or thickened areas in your breast or anywhere else on your body; unexplained stomach upset or any trouble with swallowing; an obvious change in a wart or a mole; a nagging cough or hoarseness; night sweats.
  • Vomiting or diarrhea may stop Cyclosporine from being absorbed (going) into your body.

Be sure to tell your doctor right away if you notice any of these symptoms listed above, and especially if they continue, bother you in any way, or seem to increase in intensity. Remember, only a doctor can tell if these symptoms might be from Cyclosporine. If you think you are having side effects, talk to your doctor right away. Do not stop taking this drug your own.

Ulcers

Convulsions

Allergic reactions

This is not a complete list of side effects. For any unexpected effects while taking Cyclosporine, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep CYCLOSPORINE out of the reach of children. A child who accidentally takes this drug may be seriously harmed. A locked drawer or cupboard is best if you have small children in the house.
• CYCLOSPORINE capsules should be kept in a dry place, at a temperature between 15 and 25°C. Remember to leave each capsule in its foil pack until you need to take it.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

Toll-free telephone: 1 866-234-2345

Toll-free fax: 1 866-678-6789

By email: cadrmp@hc-sc.gc.ca

Website: www.healthcanada.gc.ca/medeffect

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document, plus the full Product Monograph prepared for health professionals, can be obtained by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062

or

by written request at:

145, Jules-Léger

Boucherville, (QC), Canada

J4B 7K8 or by e-mail at :

medinfo@sandoz.com

Last revised: October, 2009